Sun.May 07, 2023

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‘The luckiest of the unlucky’: A Duchenne gene therapy brings hope to families — and tests the FDA

BioPharma Dive

Patient advocates and doctors are anticipating an approval this month of a treatment they believe to be a breakthrough for a deadly disease. But it’s not clear how well the therapy really works, putting the FDA in a difficult position.

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Sun Pharma recalls over 24000 prefilled syringes of infertility drug in US

Express Pharma

Sun Pharmaceutical Industries is recalling 24,194 pre-filled syringes of Fyremadel (ganirelix acetate) injection, a drug used to treat infertility in women, in the US market due to a manufacturing issue, according to USFDA. The company is recalling the affected lot due to the presence of particulate matter, the US FDA said. “A piece of glass was found in a prefilled syringe,” it added.

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Rise and Recognition

PharmExec

This year marks my first involvement in Pharmaceutical Executive’s Emerging Pharma Leaders (EPL) Awards, and what a ride it has been. We received so many wonderful nominations, and it’s always humbling to learn about some of the intricacies of the research that’s being done as well as the accomplishments of both current leaders and up-and-coming leaders.

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Episode 815: Does Lactic Acidosis From Epinephrine Always Mean a Poor Outcome?

Pharmacy Joe

In this episode, I’ll discuss lactic acidosis from epinephrine. Episode 815: Does Lactic Acidosis From Epinephrine Always Mean a Poor Outcome? Subscribe on iTunes , Android , or Stitcher Epinephrine is a treatment for disease states that can cause elevated lactate such as anaphylaxis and sepsis, but epinephrine also has a known side effect of raising lactic acid levels.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Formosa, AimMax submit NDA to FDA for new pain therapy

Pharmaceutical Technology

Formosa Pharmaceuticals along with AimMax Therapeutics has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for APP13007, a new formulation to treat inflammation and pain after ocular surgery. APP13007 is an aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%). The homogeneous nanosuspension looks like a solution that provides improved comfort to the eyes and helps drug penetrate well into ocular tissues.

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TO BE CONTINUED (!?): DEA Announces It is Issuing a “Temporary Rule” to Address Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency

FDA Law Blog: Biosimilars

By Karla L. Palmer — On May 3, 2023, DEA’s Administrator Anne Milgram issued a very brief and lightly publicized statement announcing that DEA intends to issue a “temporary rule” extending telemedicine flexibilities that existed during the COVID-19 Emergency Declaration, which Declaration is set to expire on May 11, 2023. Most notably for the millions of patients who, for over three years, have depended on telemedicine solutions to receive needed controlled substance medications, the Declaratio

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As FREE As Amazon Will Let Me! MPJE Federal Law Book – Offer Will End Soon!

Med Ed 101

I enjoy giving back to those who follow the blog closely and I hope this will help a lot of students and pharmacists with their MPJE preparations! I’m pricing the 2nd Edition (Bigger and Better than the first edition!) of MPJE Master as cheap as Amazon will let me. Spoiler alert – It is $0.99! […] The post As FREE As Amazon Will Let Me!

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Setting Search Engine in Internet Browser

RX Note

Introduction Google , who has been the leader in search engine , is now facing a serious challenge from Microsoft's Bing after it integrated OpenAi's technology to give ChatGPT-like responses to user queries. To illustrate, Samsung is reported planning to replace Google with Microsoft's Bing as the default search engine on its Galaxy phones and tablets.

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Pharmaceutical Executive, May 2023 Issue (PDF)

PharmExec

Click the title above for a link to open the Pharmaceutical Executive April 2023 issue in an interactive PDF format.

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Bliss Biopharmaceutical Entered into a Clinical Trial Collaboration Agreement with Eisai for BB-1701 to Treat Cancers

PharmaShots

Shots: BlissBio will receive up front & milestones. If Eisai exercises its option, BlissBio will also receive an option exercise fee, ~$2B in development & commercial milestones along with royalties. Both companies will conduct co-development activities related to BB-1701 through an option period Upon the option exercise, Eisai to get a right globally (excl.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Which pharmaceutical companies have the most SPCs in France?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in France. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in France? appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma á la carte – 5/9/23

The Honest Apothecary

Here I share some of the latest news, articles, editorials, or blog posts that fall generally under the theme of Pharma or healthcare. I might throw in a something off-topic from time to time which I found while wandering throughout the endless hallways and corridors of the internet. All article shared will be free to read and not locked behind an annoying paywall.

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CSIR-IICT signs MoU with 101 Therapeutics, Israel for COVID-19 drug

Express Pharma

The CSIR-Indian Institute of Chemical Technology (CSIR-IICT) recently signed an MoU with 101 Therapeutics, Israel for clinical trials for a medication to treat COVID-19 drug. As per the three-year agreement, CSIR-IICT will be the knowledge partner for the clinical trial study and 101 Therapeutics, a CRO will manufacture the drug. This is an intravenous macrophage-targeting drug conjugate that could be administered in the initial as well as later stages of the COVID infection.

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